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Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management

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ClinicalTrials.gov Identifier: NCT00580697
Recruitment Status : Withdrawn (Nonapplicable clinical trial)
First Posted : December 27, 2007
Last Update Posted : January 25, 2021
Information provided by (Responsible Party):
University of California, Irvine

Brief Summary:
This study is to determine the prevalence of lower urinary tract symptoms in women undergoing surgery for gynecologic malignancy.

Condition or disease
Lower Urinary Tract Symptoms Gynecologic Malignancy

Detailed Description:
Lower urinary tract symptoms, including urinary incontinence, voiding dysfunction, urgency, frequency, fecal incontinence, as well as sexual dysfunction, is directly affected by gynecologic malignancies and the surgical and medical management of those malignancies. Increased risk of injury to the urinary tract is a recognized complication of surgical and medical therapy of gynecologic malignancies. To date, only a few studies have looked at the incidence of lower urinary tract symptoms at the time of diagnosis of gynecologic malignancy and prior to treatment, and there have been no published studies describing the incidence of sexual dysfunction at the time of diagnosis and prior to therapy of gynecologic malignancies. However, sexual dysfunction has been described in patients with urinary incontinence and pelvic organ prolapse and following surgery for incontinence and pelvic organ prolapse.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Lower Urinary Tract Symptoms in Women With Gynecologic Malignancy Planning to Undergo Surgical Management
Study Start Date : March 2006
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The outcome will be measured using validated general and condition-specific questionnaires. [ Time Frame: 7 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Have a diagnosis of a gynecologic malignancy: cervical, endometrial, or ovarian cancer, and plan to have surgry for the cancer treatment.

Inclusion Criteria:

  • Subjects with a new diagnosis of gynecologic malignancy who plan to undergo surgical management, including cervical, endometrial, and ovarian cancer.

Exclusion Criteria:

  • Subjects less than 18 years of age
  • Subjects unable to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580697

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United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
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Principal Investigator: Karen L Noblett, M.D. University of California, Irvine
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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00580697    
Other Study ID Numbers: 2006-4825
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: January 25, 2021
Last Verified: January 2021
Keywords provided by University of California, Irvine:
Lower urinary tract symptoms
Gynecologic malignancy
Urinary incontinence
Fecal incontinence
Voiding dysfunction
Sexual dysfunction
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations